A multi center, single arm, interventional Phase 4 study to evaluate a Treat and Extend regimen of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion - CENTERA

Bayer AG0 个研究点目标入组 160 人开始时间: 2016年5月20日最近更新: 2020年4月29日

适应症

试验速览

暂无简介。

•- Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of = 3 months since onset of macular edema at their scheduled baseline visit).
•- Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's
•routine treatment practice with the intent to use a T&E regimen after initial dosing.
•- Treatment-naïve subjects for macular edema secondary to CRVO.
•- Men and women = 18 years of age.
•- Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 32
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 128

•- Previous PRP or macular laser photocoagulation in the study eye.
•- Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
•- Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
•- Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months
•prior to Day 1.
•- Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
•- Any history of allergy to povidone iodine.
•- Known serious allergy to the fluorescein sodium for injection in angiography.
•- Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.

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